(WAYNE, PA, June, 13, 2008) — CEO & Chairman Jim Walker of Octagon Research Solutions, Inc., a pioneer and leading provider of breakthrough software and services to the life sciences industry, today announced that Octagon’s thought leaders will present during the Drug Information Association (DIA) 44th Annual Meeting. Octagon’s regulatory, clinical, process and technology experts will present in seven sessions:
• Dave Evans, chief information officer, will be presenting a session entitled, ‘Practical Applications of CDISC SDTM’ within the ‘Clinical Data Management (CDM)’ Track. This session will be held, Wednesday, June 25, 2008, 3:30 – 5:00 PM EDT.
• Patrick Thomas, associate director, Regulatory Affairs, will chair the session entitled ‘The eCTD: Lessons Learned and Practical Experience’ within the ‘Electronic Regulatory Submission/Document Management (ERS/DM2)’ Track. This session will take place Monday, June 23, 2008, 3:30 – 5:00 PM EDT.
• Mary Lenzen, principal consultant, Clinical Data Strategies, will present ‘Success at the Crossroads: The Intersection of CDISC Standards with Research Site Processes’ within the ‘Academic Health Centers/Investigative Sites (AHC/IS)’ Track. This session will take place Tuesday, June 24, 2008, 2:00 – 3:30 PM EDT.
• John Aitken, PhD, managing director, West Coast Operations, will present ‘eCTD: What It Is, What It Is Not, and What It Might Be’, within the ‘Electronic Regulatory Submissions/Document Management (ERS/DM 1)’ Track. This session will take place Wednesday, June 25, 2008, 8:30 - 10:00 AM EDT.
• Nancy Smerkanich, vice president, Regulatory Affairs will serve as session chair for ‘eCTD: Life-cycle Management (LCM)’ within the ‘Electronic Regulatory Submissions/Document Management (ERS/DM)’ Track. This session will take place Thursday, June 26, 2008, 8:30AM - 10:00AM EDT.
• Amanda Keller, senior process consultant, Europe, will co-present as session entitled ‘Global Submission Management’ within the ‘Electronic Regulatory Submissions/Document Management (ERS/DM)’ Track. This session will take place Thursday, June 26, 2008, 10:30AM - 12:00PM EDT.
• Hanming Tu, MS, director, Clinical Information Technology, will chair a session entitled ‘CDISC SDTM Data Conversion’ within the ‘Information Technology’ Track. This session will take place June 23, 1:30 PM – 3:00PM EDT.
“It is an honor to have representatives from Octagon’s regulatory, clinical, process and technology teams to be selected to present during the DIA 44th Annual Conference,” noted Jim Walker, chairman and CEO. “To have such an array of speakers is truly representative of our industry expertise and cross-functional approach.”
In addition to presenting, Octagon will be exhibiting at Booth #630 and will feature product demos and announcements of its breakthrough service and technology solutions that optimize the complex process from data collection to submission.
If you would like more information, please contact Octagon Research Solutions, Inc. at 610-535-6500, or on the web at www.octagonresearch.com.
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Berkhamsted, UK. Octagon’s EDC Operations are located in Mountain View, CA. For more information please visit www.octagonresearch.com.
